Good Manufacturing Practice (GMP) News
The PIC/s Guides to GMP
The PIC/s Guide to GMP have been updated. Of particular interest is the change to Chapter 4 on documentation which extends slightly on the EU GMPs that were updated in June 2011.
Qualified Persons (QPs) please take note!
The EMA Draft Reflection Paper on use of interactive voice response (IVR) technology to justify not including reanalysis/expiry dating on the label for clinical supplies is proposing yet another task for the QP, please see the link below; the last date for comments is 15th February 2012.
For those involved in advanced therapy medicinal products (ATMPs)
A reminder that EMA has issued a Committee for Medicinal Products for Human Use (CHMP)/Committee for Advanced Therapies (CAT) position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products, effective June 2011. See link below.
EC concept paper on the requirement for safety features in line with the falsified medicines legislation
The European Commission has issued a concept paper which has been published for consultation. Comments and suggestions are invited by 27th April 2012
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Revised code of GMP for human blood and tissues
The Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 references the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 (2013 Code of GMP). These requirements commence from 31 May 2013.